HK1221137B - Diabetes management system with a medical device - Google Patents

Description

Diabetes management system with medical devices

Technical Field

The present disclosure relates to the use of device settings, medical and usage data, and statistics utilizing a management system for patients with diabetes.

Background Art

This section provides background information related to the present disclosure which is not necessarily prior art.

People with diabetes have difficulty regulating their blood glucose levels. As a result, many of these people carry specialized portable medical devices (such as blood glucose meters) that allow them to regularly measure their glucose levels and take appropriate action, including administering insulin. After taking a blood glucose measurement or series of measurements, a diabetic patient may find it useful to transmit these measurements to their healthcare professional for further review and analysis. In this regard, a patient's blood glucose meter may be capable of storing blood glucose measurements for later review and analysis by the patient or healthcare professional, who can then record the measurements manually or electronically.

The process of measuring, storing, recording and analyzing blood glucose levels can be a very time-consuming process for both the patient and the patient's healthcare professional. The exchange and review of data may require a meeting between the patient and the healthcare professional. People with diabetes are generally searching for better and more efficient ways to manage their health. In addition, healthcare professionals need new ways to encourage people with diabetes to communicate more effectively. Technology can provide a feasible platform for software applications for a variety of consumer requirements. Moreover, many people with diabetes use personal computers and/or mobile devices in their daily lives.

Summary of the Invention

This application claims the benefit of U.S. Provisional Application Nos. 61/816,642 and 61/816,659, filed April 26, 2013. The entire disclosure of each of the above applications is incorporated herein by reference.

This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

The object of the present invention is to provide an improved diabetes management system and a corresponding method as specified in the independent claims. Various embodiments and enhancements thereto are given in the corresponding dependent claims. The embodiments and features described in the following paragraphs can be freely combined with one another, if they are not mutually exclusive.

In one aspect, the present invention relates to a diabetes management system for monitoring multiple subcutaneous insulin therapy. The system includes a portable medical device associated with a patient and a data repository accessible to both the patient and a healthcare provider. The system also includes a diabetes management application configured to receive data from the portable medical device and store it in the data repository. The data may include medical data associated with the patient and usage data associated with the patient's use of the portable medical device. The diabetes management application may be configured to accumulate and evaluate statistics related to the medical data or usage data and provide treatment recommendations to the patient or healthcare provider when the statistics meet or exceed predetermined treatment criteria.

The features described herein can improve the effectiveness and efficiency of storing, transmitting, and analyzing blood glucose measurements. Patients and their healthcare professionals can be enabled to send data, including blood glucose measurements, to a centralized electronic data repository for later retrieval and analysis. This can help improve the management and treatment of diabetes. The features described herein can also help ensure adherence to treatment regimens and improve glycemic control. Collecting and statistically evaluating usage data related to patient compliance can help assess and monitor patient and/or responsible healthcare provider adherence to treatment regimens.

In another aspect, the present teachings provide a method for sharing information and managing diagnosis and treatment of patients with medical conditions. The method includes providing a web portal account accessible to both the patient and the healthcare provider at one or more servers. The web portal account can be associated with a portable medical device. The method includes receiving medical data and usage data from the portable medical device at one or more servers; the medical data can be associated with the patient and the usage data can be associated with the patient's use of the medical device. Statistics related to the medical data or usage data are accumulated at one or more servers. The statistics can be accumulated over a period of time and can be accessed in the web portal account. The method includes evaluating the statistics in relation to treatment criteria at one or more servers; and sending a treatment recommendation from the one or more servers to the patient or the healthcare provider when at least one statistic meets or exceeds a predetermined treatment criterion.

According to an embodiment, a patient is taking a course of multiple subcutaneous insulin injections as part of diabetes treatment.

According to an embodiment, the statistic is indicative of at least one of blood glucose measurement, carbohydrate consumption, medication therapy, basal rate, and compliance with treatment recommendations.

According to an embodiment, the method further comprises accumulating statistics from a plurality of portable medical devices associated with the patient.

According to an embodiment, the method further comprises remotely adjusting, from the one or more servers, at least one device setting on the portable medical device based on the treatment recommendation.

According to an embodiment, the device settings include at least one of an insulin:carbohydrate ratio, a basal rate, a maximum dosage, a calibration setting, a utility setting, and an alarm setting.

According to an embodiment, the usage data includes data indicative of the patient's compliance with medication therapy recommendations.

According to an embodiment, the treatment recommendation is sent as an electronic message to the portable medical device.

According to an embodiment, the method further comprises soliciting input from a healthcare provider before sending the treatment recommendation to the patient.

According to an embodiment, the method further includes providing one or more proposed treatment recommendations to a healthcare provider, wherein the healthcare provider selects at least one proposed treatment recommendation for sending to the patient.

According to an embodiment, the treatment recommendation includes at least one of a reminder regarding eating habits, a reminder to transfer data from the portable medical device to the web portal account, a reminder to test blood glucose levels, a correction basal rate change recommendation, and a correction medication dosage recommendation.

According to an embodiment, data associated with the web portal account is accessible via the portable medical device.

In other aspects, the present teachings provide a method for managing and treating diabetes in a patient who is participating in a course of multiple subcutaneous insulin injections. The method includes providing a web portal account accessible to both the patient and the healthcare provider at one or more servers. The web portal account can be associated with a portable medical device. Medical data and usage data are received from the portable medical device at one or more servers. The medical data can be associated with the patient and the usage data can be associated with the patient's use of the portable medical device. The method includes accumulating statistics related to the medical data or usage data at one or more servers. The statistics can be accumulated over a period of time and accessible in the web portal account. The statistics are evaluated at one or more servers in relation to treatment criteria and can be associated with the web portal account for access by one or both of the patient and the healthcare provider. The method includes providing a treatment recommendation to the patient or the healthcare provider when at least one statistic meets or exceeds a predetermined treatment criterion.

According to an embodiment, the steps of providing a web portal account, receiving medical data and usage data, accumulating statistics related to the medical data or usage data, evaluating the statistics, and providing treatment recommendations to the patient or healthcare provider may be performed by the same set of one or more servers.

According to an embodiment, the treatment recommendation includes adjusting the patient's insulin:carbohydrate ratio.

According to an embodiment, the method further comprises sending the treatment recommendation as an electronic message from the one or more servers to the portable medical device.

According to an embodiment, the method further comprises remotely adjusting, from the one or more servers, at least one device setting on the portable medical device based on the treatment recommendation.

According to an embodiment, the device settings include at least one of an insulin:carbohydrate ratio, a basal rate, a maximum dosage, a calibration setting, a utility setting, and an alarm setting.

According to an embodiment, a healthcare provider selects a statistic for evaluation.

According to an embodiment, the method of any one of the above-described embodiments is implemented and executed by one or more computers (eg, one or more servers).

Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

FIG1 is a diagram depicting an exemplary diabetes management system;

FIG2 is a diagram depicting a software architecture system for a diabetes management system;

FIG3 is a diagram depicting an alternative embodiment of a diabetes management system;

FIG4 is a diagram depicting an alternative embodiment of a software architecture system for the diabetes management system shown in FIG3 ;

FIG5 is a diagram depicting yet another alternative embodiment of a software architecture system for the diabetes management system shown in FIG3 ;

6 is a flow chart illustrating one embodiment of a method of sharing information and managing diagnoses for patients having medical conditions;

7-13 illustrate various graphical user interfaces that may be used with the diabetes management system, management application, web browser, web portal account, and related software architecture; and

14 is a diagram depicting the operation of an embodiment of a diabetes management system.

Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference to the accompanying drawings.

While the use of an insulin pump is manageable for many patients with diabetes, other patients decide to use a course of multiple subcutaneous injections (MDIs), which can allow for more changes in lifestyle. However, along with changes in lifestyle, patients must be aware of the importance of carefully monitoring their diabetes regimen and proactively performing blood glucose testing and insulin administration. The present disclosure provides systems and methods for improved diabetes management, including the ability to detect, identify, and remedy certain situations in which patients with diabetes deviate from prescribed therapy. In various aspects, when inconsistencies or discrepancies are detected, assessed, or otherwise identified from the settings of a portable medical device and/or related medical data and usage data or statistics obtained therefrom, the systems and methods provided herein can help provide various treatment recommendations. The assistance can include evaluating the medical data, usage data, and device settings, and determining one or more appropriate treatment recommendations for consideration by the patient or healthcare provider.

In various aspects, the diabetes management system can provide treatment recommendations that include setting changes for portable medical devices, changes in insulin dosing and blood glucose testing, reminders, alarms, or even motivational statements based on compliance factors, with the goal of increasing compliance with the treatment regimen and ultimately providing improved glycemic control.

Treatment adherence issues can be common for some individuals with diabetes, which often makes glycemic control difficult to achieve. Because the risk of diabetic complications can be reduced through proper adherence, patient failure to adhere to treatment recommendations can be frustrating for both diabetic patients and their healthcare professionals. Studies have shown that adherence rates for chronic disease treatments and for lifestyle changes are roughly around 50%. According to various implementations of the diabetes management system of the present disclosure, usage data related to patient adherence can be collected and evaluated through statistical analysis for review and monitoring by patients and healthcare providers. Usage data related to adherence can include, for example, the number and timing of blood glucose measurements taken during a specified period; the number, amount, and timing of medications administered; the number, amount, and timing of corrective treatments administered; recording of meal data and carbohydrate information, exercise routines, data uploads, illnesses, taking prescribed medications or medical treatments, attending medical appointments, behavioral changes, etc.

For patients with MDI basic medication diabetes treatment course, basic and medication treatment should be carefully configured and monitored. Basal rate determination and correction can change based on individual patient requirements and change cycle. For example, the factors that may affect basal rate can include growth spurt, weight gain or weight loss, new or revised medication, hormonal changes, changes in eating and prolonged fasting, sleep changes, exercise routine changes, long-term inactivity, disease, stress and seasonal changes. About medication insulin dispatch, carbohydrate counting and insulin to carbohydrate ratio are two important tools for matching insulin and food. For correct medication, diabetic patients will need to calculate the approximate number of carbohydrates in each meal, and know his or her insulin to carbohydrate ratio. Portable medical equipment can be pre-programmed with the patient's specific ratio, which can be adjusted as needed. Insulin: carbohydrate ratio can be used to calculate the dosage of insulin for each meal and/or snacks.

As an example, a person on a diabetes regimen with an insulin:carbohydrate ratio of 1:5 would take 5 units of rapid-acting insulin as medication to cover a meal containing 50g of carbohydrates, in addition to their basal insulin. This calculation can typically be determined on a trial-and-error basis, and for type 2 diabetics with severe insulin resistance, the number can be much higher. A standard ratio might be 1:15. By examining statistics and historical data for a given patient, a healthcare provider can provide updated treatment recommendations related to this ratio. In one example, a healthcare provider can look at the insulin:carbohydrate ratio and see that it has historically been set at 1:20. In another example, a patient may routinely have a blood sugar level within range before a meal, but approximately 2-3 hours after the meal, the blood sugar level remains high. This could be another example where reducing the insulin:carbohydrate ratio could be beneficial. If a patient's blood sugar levels are consistently unacceptable, a healthcare provider can use the web portal of the present technology and look at statistics, usage data, device settings, and other factors such as exercise, food intake, and compliance data to ultimately determine that the patient is not receiving enough insulin for the carbohydrates they consume. The healthcare provider can then provide a treatment recommendation, for example, to adjust the ratio to 1:15 to compensate for the blood glucose level. In certain aspects, the web portal can collaborate with the diabetes management system disclosed herein to provide collected statistics related to factors of interest to healthcare providers, such as patient exercise routines, food intake, and usage/adherence data. Various data can be uploaded by the patient to the web portal and the diabetes management system.

With reference to the above issues, and with the goal of developing diabetes treatments, FIG1 illustrates an exemplary diabetes management system ("DMS") 10 for storing and transmitting medical data, usage data, portable medical device settings, and accumulating and evaluating statistics and other relevant information available across a distributed computing environment. As non-limiting examples, such medical data, usage data, and related information may include blood glucose measurements, carbohydrate consumption, basal rates, medication regimens, compliance information and statistics, user and device settings, alarms and reminders, physician appointments, laboratory test results, user-entered notes, reports and charts, and location information.

The diabetes management system 10 may generally include a patient data system 12, a healthcare professional data system 14, a network 16, and one or more server computers 18. As will be explained in greater detail below, the diabetes management system 10 may be configured such that data and information is electronically sent to and received from the patient data system 12, the healthcare professional data system 14, and the server computers 18 via the network 16.

The diabetes management system 10' illustrated in FIG3 may also generally include a portable medical device 28, such as a recording device or a blood glucose meter, for measuring and storing certain medical data or information, including blood glucose measurements.

The portable medical device 28 can be, for example, a handheld device comprising a port configured to receive a medical test strip having a reaction area for receiving a liquid sample from a patient. The portable medical device 28 can include an internal blood glucose meter that can operate in cooperation with a test strip inserted in the port and is configured to measure the glucose in the liquid sample residing in the strip and associate identification information with the glucose measurement. The portable medical device 28 can also include a user interface that selectively provides instructions, messages, and/or treatment recommendations to the patient. The portable medical device 28 can be paired with other portable devices such as a mobile communication device, a laptop computer, a tablet, or other devices that can cooperate with the portable medical device 28 and display instructions, messages, reminders, alarms, treatment recommendations, etc.

The portable medical device 28 may be operable to transmit medical data, usage data, or other relevant information to at least one of the patient computing device 20 and the healthcare professional computing device 24 via a data transmission device incorporated therein, such as a hardwired data port or a wireless data port such as a Bluetooth receiver. The portable medical device 28 may be associated with a unique identifier or security code attached to any data transmitted by the portable medical device. Thus, in this data transmission method, the patient or other user may not be required to enter a username, password, or other security code before transmitting data via the network 16.

It should be understood that a patient can operate multiple portable devices to manage their diabetes treatment. The devices can be the same or different in function and/or design. It is contemplated that each device can be used with a diabetes management system and that multiple devices can transmit data manually or automatically.

The patient data system 12 may include at least one patient computing device 20 operatively connected to and in communication with the network 16 via a wired or wireless connection, such as WiFi. By way of example, the patient computing device 20 may be a desktop computer or a mobile communication device, such as an electronic tablet or smartphone. The patient computing device 20 may include a data input device, a processor, a memory, and an output device. The data input device may be a touch screen, a keyboard, a mouse, a microphone, a hardwired data port, such as a universal serial bus (USB) port, or a wireless data port, such as a Bluetooth receiver. The processor may be connected to the data input device, the memory, and the output device. In an exemplary embodiment, the processor comprises a general-purpose processor. In another exemplary embodiment, the processor comprises an application-specific integrated circuit (ASIC). Output devices may include a display, a speaker, and the like.

1 and 2 , in one embodiment of the patient data system 12, a user (e.g., a patient) may enter medical data, usage data, or other relevant information, such as blood glucose measurements, into an account on a web-based system or patient computing device 20 via a data entry device for transmission via a network 16. Prior to entering or transmitting data via the network 16, the user may be required to enter a username, password, or other security code to ensure accurate transmission and storage of the data.

The healthcare professional data system 14 may include at least one healthcare professional computing device 24 operatively connected to and in communication with the network 16 via a wired or wireless connection, such as WiFi. A physician or other person with appropriate credentials to access the healthcare professional computing device 24 may utilize the network 16 to download and view medical data, usage data, or other relevant information, such as blood glucose measurements, stored on the server computer 18. By way of example, the healthcare professional computing device 24 may be a desktop computer or a mobile communication device, such as an electronic tablet or a smartphone.

The healthcare professional computing device 24 may include a data input device, a processor, a memory, and an output device. The data input device may be a touch screen, a keyboard, a mouse, a microphone, a hardwired data port such as a Universal Serial Bus port, or a wireless data port such as a Bluetooth receiver. The processor may be connected to the data input device, the memory, and the output device. In an exemplary embodiment, the processor comprises a general-purpose processor. In another exemplary embodiment, the processor comprises an application-specific integrated circuit. Output devices may include a display, a speaker, and the like.

1 and 2 , one or more server computers 18 may include a processor, input devices, output devices, and memory including a database or data repository 26. The processor is connected to the memory, input devices, and output devices. In an exemplary embodiment, the processor comprises a general-purpose processor. In another exemplary embodiment, the processor comprises an application-specific integrated circuit. Input devices include a keyboard, a mouse, a touchpad, a trackpad, etc. Output devices include a display, a speaker, etc. The server computer 18 and the database 26 may be operably connected to and in communication with the network 16 via a wired or wireless connection. The server computer 18 may be operable to send and receive data, such as blood glucose measurements received from the patient data system 12, to the database 26 via the network 16 for storage and later retrieval. As will be discussed below, data and information sent via the network 16 may be assigned to a unique web portal or equivalent patient account before being stored in the database 26 located on the server computer 18 or otherwise accessible by the server computer 18.

FIG3 illustrates an alternative embodiment of a diabetes management system 10′. The alternative embodiment of the diabetes management system 10′ can be similar to the embodiment shown in FIG1 and include a patient data system 12, a healthcare professional data system 14, a network 16, and at least one server computer 18. The patient data system 12 can include at least one patient computing device 20 operatively connected to and in communication with the network 16 via a wired or wireless connection, such as WiFi. The healthcare professional data system 14 can include at least one healthcare professional computing device 24 operatively connected to and in communication with the network 16 via a wired or wireless connection, such as WiFi, through which a physician or other person with appropriate access to the healthcare professional computing device can download and view medical data, usage data, or other relevant information, such as blood glucose measurements, sent from the patient computing device 20 via the network 16.

The portable medical device 28 may be configured to transmit data to at least one of the patient computing device 20, the healthcare professional computing device 24, and the one or more server computers 18 at regular, programmable intervals, at user-selected varying times, in real time as blood glucose measurements are taken, or when blood glucose measurements reach certain threshold device-set levels that may be set and remotely adjusted by the patient or healthcare professional.

4 , one embodiment of a software architecture system 30 is illustrated for use with the diabetes management system 10. The software architecture system 30 may be operable to allow the transfer and manipulation of medical data, usage data, and other relevant information, such as blood glucose measurements, from the portable medical device 28 and between the patient data system 12, one or more server computers 18, and the healthcare professional data system 14 over the network 16.

The software architecture system 30 may include a device transfer component 32. The device transfer component 32 may be stored on one or more server computers 18 for transmission and installation on patient computing devices 20 and healthcare professional computing devices 24 via the network 16. Installation of the device transfer component 32 on a patient computing device 20 or healthcare professional computing device 24 allows such device to send data and information, such as blood glucose measurements, to a diabetes management application 33 installed on the server computer 18. When a portable medical device 28 sends data to the patient computing device 20 or healthcare professional computing device 24, the device transfer component 32 may be operable to pass the data to the server computer 18 via the network 16 without storing the data on the device transfer component 32 or the patient computing device 20. A medical device application 34 may be installed on the portable medical device 28 to facilitate data and information exchange with the device transfer component 32, as described above. Data sent via the device transfer component 32 may include an identifier code unique to the specific patient and/or portable medical device 28 from which the data was received. The identifier code may allow device transfer component 32 and database 26 to efficiently send, store, and retrieve data from a unique location within database 26 or a patient account.

Before transferring data and information over the network 16, the user may be required to link or associate the portable medical device 28 with a unique patient account created on or accessible to one or more servers 18. Authentication can be accomplished by first allowing the portable medical device 28 to communicate with the patient computing device 20 via an input device such as a USB port or a Bluetooth receiver. The portable medical device 28 may be assigned a unique identification code or authentication token. After downloading and running the device transfer component 32 and allowing the portable medical device 28 to communicate with the personal computing device 20, the authentication token for the portable medical device may be assigned to the appropriate patient account. Once the authentication token for the portable medical device 28 has been assigned to the patient account, medical data, usage data, and other relevant information may be transferred and assigned to the appropriate patient account in the database 26 via the device transfer component 32.

In an alternative embodiment of the data transfer process, the device transfer component 32 may be assigned a unique identification code. Prior to transferring data and information from the portable medical device 28 via the network 16, the user may be required to associate the unique identification code of the device transfer component 32 with the patient's account. The data and information from the portable medical device 28 may be linked to the unique identification code of the device transfer component 32 prior to transmission via the network and, therefore, assigned to the appropriate patient account in the database 26.

After data has been transferred from the device transfer component 32 to a patient account located on the server 18, the software architecture system 30 may allow such data to be further transferred from the patient account to an authorized health professional computing device 24 and a patient computing device 20 via the device transfer component 32. The transfer of data from the patient account in the database 26 located on the server 18 may require linking the patient account with the device transfer component 32 installed on the health professional computing device 24.

The software architecture system 30 may also allow patients, healthcare professionals, or other users to create customized reports relating to the data and information contained therein or to perform research on information contained within or external to the software architecture system. In addition, the software architecture system 30 may be operable to provide data backup and recovery services regarding data and information that may be lost from the patient data system 12 or the healthcare professional data system 14.

Referring to FIG5 , another embodiment of a software architecture system 30 for use with the diabetes management system 10 is illustrated. A database 26 on the server computer 18 can communicate with an accumulator device or module 36 configured to accumulate statistics related to medical data and usage data over a specified time period. The database 26 can also communicate with a statistics evaluator device or module 38 configured to collect, evaluate, and generate statistics related to the medical data and usage data for use by the diabetes management system 33. The statistics evaluator 38 can communicate with a recommendation rule set 40 containing baseline information and standards related to the collected and analyzed medical data and usage data, as well as information related to various treatment guidelines that can be programmed therein. Treatment guidelines can include minimum and maximum acceptance values, as well as boundaries for normal and out-of-range data and/or statistics. In various aspects, the recommendation rule set 40 can be updated or modified by an administrator or healthcare provider. The accumulator device 36 and statistics evaluator 38 can be evaluated by the diabetes management system application 33.

2 , in another embodiment of a software architecture system 30′, a user may send and receive data from one or more server computers 18 and databases 26 via a web browser on a patient computing device 20, instead of downloading and utilizing a device transfer component 32 on the patient computing device. In the software architecture system 30′, the server computer 18 may include a device transfer component 32 that allows a user to send data and information to the server computer 18 for storage in the database 26 and for further transmission to the healthcare professional computing device 24 via the network 16. The user may access the diabetes management system 10 and the software architecture system 30′ by entering a URL designated for the diabetes management system directly into a web browser.

Before transferring data to the server computer 18 via the network 16, the user may be required to create a unique patient account and security credentials, such as a username and password, to ensure a unique and secure storage location in the database 26. The user may also be required to associate or link a portable medical device 28 verification token with the patient account. Once the user has created a patient account and linked the portable medical device 28 verification code to the patient account, the user may be permitted to transfer data and information to and from the server computer 18 without otherwise logging into the patient account. In one aspect of the diabetes management system 10, access to the server 18 via a web browser may allow the user to transfer data, such as blood glucose measurements, patient weight, meal information, and the like, to the patient account in the database 26. In another aspect of the diabetes management system 10, access to the server 18 via a web browser may allow the user to create and view reports, charts, and other information based, at least in part, on data transferred from the user.

Communications between the patient data system 12, the healthcare professional data system 14, and the server computer 18 may utilize HTTP Basic Authentication combined with the Secure Sockets Layer (SSL) security protocol. Other communication and security protocols known in the art are also contemplated.

In various aspects, the present technology uses a web portal that communicates with a diabetes management system or management application to perform various functions involving healthcare provider accounts, patient accounts, or both. A web browser or web-based application can be used to perform similar functions. For example, a healthcare provider can be provided with a first or primary web portal account to help manage the treatment of multiple different patients, each patient having a corresponding patient account accessible from a server computer associated with the diabetes management system. The healthcare provider may be able to configure its account to display certain data, statistics, and/or usage data from various patients having web portal patient accounts accessible through the healthcare professional's account. Review of the data can allow the healthcare provider to better assess the patient's health and adjust the course of treatment based on the latest and historical data.

7-13 illustrate exemplary graphical user interfaces (GUIs) that may be used with the diabetes management system, management application, web browser, web portal account, and related software architecture.

At various points during the use of the diabetes management system, access to information and the processing of requests or changes can be verified. Verification can be accomplished using various techniques, including but not limited to verification of username and/or password credentials, permissions, unique identifiers, security questions or other identifications. Verification can also include solicitation or confirmation of one or more users, which seeks confirmation or acknowledgment of the request made. Figures 7 and 8 illustrate a GUI welcome screen. In one example, the welcome screen can begin the verification process and subsequently provide access to account information, history, statistics, and data including blood glucose, insulin, and carbohydrate values manually entered, uploaded, or otherwise obtained from the handheld or portable medical device used by the patient, and an overview of selected features.

In addition to typical logic and test information generally considered useful for diabetes treatment and management control, the web portal can be configured to collect and use the geographic location of the healthcare provider and/or patient in order to comply with certain regulations and/or compliance regimens that may exist for different geographic locations, such as different states or countries. Various portions of the data, such as references to medical patient data and personal data, can be encrypted for patient security and confidentiality.

FIG6 is a flow chart illustrating an embodiment of a method for sharing information and managing diagnoses for patients with medical conditions. Referring to method step 100, a web portal account can be created on one or more servers. The account can be created by an appropriate administrator or healthcare provider. The web portal account can then be associated with a specific patient and/or portable medical device, as shown in step 110. As discussed above, appropriate access rights and authorizations are provided to the patient and healthcare provider, as shown in step 120. In various aspects, patients and/or healthcare providers (authorized users) with appropriate credentials can access various data stored in the diabetes management system. For example, an authorized user can review historical data and determine treatment recommendations based on the data stored therein.

Referring to step 130, medical data and usage data are received from the portable medical device. In various aspects, a patient can log into the diabetes management system to manually enter or record medical data such as blood glucose measurements, insulin values, meal information, compliance evidence, etc. The information can also be automatically transferred to the system by the patient or healthcare provider. As discussed above, a user such as a patient or healthcare provider can connect one or more portable medical devices to the diabetes management system and navigate to the device within the system. The user can then select the appropriate device (if more than one device is connected) and instruct the system to transfer medical data, usage data, and/or user settings to the diabetes management system. The data can be transferred to a web portal account in batches or after each measurement is taken.

With reference to steps 140 and 150, statistics may be accumulated over a period of time, wherein the accumulator device 36 and the statistics evaluator 38 analyze the medical data and the usage data with respect to the treatment guidelines, as discussed above. The statistics may be associated with an appropriate web portal account for access by the patient and the healthcare provider, as shown in step 160.

In various aspects, referring to step 170, when at least one statistic meets or exceeds a treatment criterion, a treatment recommendation can be sent to the patient or healthcare provider. The treatment recommendation can include instructing the patient to adjust user or device settings on one or more portal medical devices. Device settings can include, for example, when the device takes a measurement, when the device delivers insulin (if applicable), when the device reminds the patient to eat, standard insulin:carbohydrate ratio, basal rate, maximum dosage, calibration settings, utility settings, and alarm settings.

Various device settings can be uploaded to the diabetes management system. In certain aspects, at least one device setting of the portable medical device can be remotely adjusted, for example, from one or more servers, with adjustments optionally authorized, approved, or initiated by a healthcare provider based on a desired treatment recommendation. As an example, the healthcare provider can adjust one or more settings using a web portal, and the next time the portable medical device is connected to the diabetes management system, the device settings will be synchronized with the portable medical device. In certain aspects, logic in the diabetes management application can be programmed to solicit input from the healthcare provider before sending a treatment recommendation to the patient.

For example, one or more proposed treatment recommendations and/or suggested device setting changes can be made available to a healthcare provider, and the healthcare provider selects at least one proposed treatment recommendation for transmission to the patient, or a device setting change to be made to the portable medical device. Once the device setting change is accepted and made to the device, the device can provide a confirmation message to the diabetes management system. The confirmation message can also be provided to the healthcare provider, for example, via a message, email, or alert made through a web portal, or directly to the healthcare provider through the use of the portable device.

In another example, a patient can upload multiple device settings to a diabetes management system. The upload process can be manual or automatic, depending on the portable medical device. The patient can grant access rights to a healthcare provider to view and adjust the device settings stored in the diabetes management system. The healthcare provider can connect to the diabetes management system via a web browser and a networked web portal account. After reviewing the patient data, which can include review of other relevant data in addition to device settings or usage data (such as food intake, exercise routine, etc.), treatment recommendations can be submitted for display through the diabetes management system using the web portal account and can also be provided directly to the portable medical device as an electronic message, alarm, or reminder.

FIG9 illustrates the device settings for a particular portable medical device such as the Accu-Check 360°. As shown, the device settings may include preferred measurement units and warning parameters, such as high and low blood glucose measurement limits. The device settings may include features related to medication recommendations, including upper and lower blood glucose units, insulin:carbohydrate ratios, and insulin sensitivity factors. Various health event settings may be provided for exercise routines. Options may be available to the user to enable or disable certain features. Groups of settings may be saved as templates, and previous settings may be saved in archives for later review, statistical analysis, and historical purposes.

FIG10 illustrates a summary interface for multiple devices used by a patient. In this regard, a patient may have a first portable medical device for home use and a second portable medical device for office use. As shown, a mobile communication device may also be configured for the selected patient account. Each device may have its own settings and reports, and the interface may provide a list of various data including the last upload date and time for each device. In various aspects, the displayed information may be filtered, selected through templates, and otherwise customizable by the user. Software updates and installers may also be available through the interface.

An example of a device settings report for a particular device is illustrated in Figure 11. The report may include reminders for physician appointments, lab tests, pump reminder settings, test reminder events, injection reminders, and other alarm features.

12-13 , the diabetes management system can collect statistics indicating the number of times medical data or usage data stored elsewhere in one or more portable medical devices has been synchronized with data stored in a database or data repository. For example, one or more server computers can increment a first counter each time medical data or usage data is uploaded or otherwise entered into the data repository. The value of the first counter can be displayed in response to a user request to view the number of times data stored elsewhere has been synchronized with data stored in the data repository. The counter can be filtered, for example, by date, device, data type, etc.

In other aspects, the server computer can additionally or alternatively collect statistics indicating the number of times the portable medical device has been synchronized with the diabetes management system. For example, the server computer can increment a second counter each time the portable medical device is synchronized. The value of the second counter can be filtered and displayed in response to a patient or healthcare provider request to view the number of times the portable medical device has been synchronized.

The server computer may additionally or alternatively collect statistics indicating the number of patients who have logged into their web portal accounts and/or reviewed messages or treatment recommendations provided to patients via their web portal accounts. For example, the server computer may increment a third counter each time a patient logs into their web portal account. The value of the third counter may be filtered and displayed in response to a user request to view the number of times a patient has logged into their web portal account.

The server computer may additionally or alternatively collect statistics indicating the number of interactions the patient has with the healthcare provider.For example, the server computer may increment a fourth counter each time the patient visits or otherwise interacts with the healthcare provider.

In various implementations, additional counters may be used, for example, with reminders and a number of compliance statistics, as discussed in more detail below. The server computer may reset the above-referenced counters at predetermined intervals, such as once a day, once a week, etc. The predetermined intervals may be updated as needed.

By utilizing a diabetes data management system, healthcare providers and patients can easily store and later access medical information related to the patient to, for example, analyze historical information regarding the patient's physiological condition, operation of portable medical devices, treatments, treatment results, personal habits, etc. Based on such historical data, healthcare providers and/or patients can be able to identify trends, beneficial practices, adverse practices, etc., and thereby adjust or design a treatment plan that utilizes beneficial trends and practices and avoids adverse trends and practices. In certain aspects, the data management system includes certain pre-programmed logic that evaluates certain statistics and/or patient device settings and alerts the patient or healthcare provider when the statistics or information are outside of predetermined changes or treatment guidelines.

Based on usage statistics received from one or more portable medical devices, the diabetes management system can collect and analyze information related to the recommended amount of insulin relative to the amount of insulin administered and/or the recommended number of blood glucose measurements taken per predetermined period (e.g., daily, weekly) relative to the actual number of blood glucose measurements taken.

The diabetes management system may include software for generating or otherwise providing reports containing information received from a patient, a group of patients, or multiple groups of patients within the same healthcare provider account. In this way, a patient or a patient's healthcare provider can easily access formatted reports of information about the patient's condition, historical conditions, operation or condition of the patient's portable medical device, or similar information about one or more defined patient groups. The reports can be formatted in various predefined formats provided by the diabetes management system. Alternatively or in addition, the system can allow the patient and/or healthcare provider to design their own report formats, including determining what type of information to include in the report and how to filter, present, display, etc. Various aspects of the present disclosure are directed to a comprehensive system capable of collecting and managing patient information for multiple patients, multiple patients having multiple different types of medical devices.

It should be understood that the sharing of accounts and data and the maintenance of appropriate data repositories can be managed by various administrative guidelines. Such administrative guidelines may require following certain procedures for opening, closing, and deactivating both patient and healthcare provider accounts associated with data sharing and storage.

The owner of the diabetes management system or the healthcare provider themselves may be provided with certain predetermined procedures and/or parameters for use through a web portal or web-based browser/application through which they perform various functions involving the healthcare provider account, the patient account, or both.

The techniques described herein can be implemented by one or more computer programs executed by one or more processors. The computer programs include processor-executable instructions stored on a non-transitory, tangible, computer-readable medium. The computer programs may also include stored data. Non-limiting examples of non-transitory, tangible, computer-readable media are nonvolatile memory, magnetic storage devices, and optical storage devices.

Some portions of the above description present the techniques described herein in terms of algorithms and symbolic representations of operations on information. These algorithmic descriptions and representations are a means for those skilled in the art of data processing to most effectively convey the essence of their work to others skilled in the art. When described functionally or logically, these operations are understood to be implemented by computer programs. Additionally, it has been demonstrated that it is sometimes convenient to refer to these arrangements of operations as modules or by functional names without loss of generality.

Unless specifically stated otherwise, as is apparent from the above discussion, it will be appreciated that throughout the description, discussions utilizing terms such as "processing" or "computing" or "calculating" or "determining" or "displaying" etc. refer to actions and processes within a computer system or similar electronic computing device that manipulate and transform information represented as physical (electronic) quantities within the computer system memory or registers or other such information storage, transmission or display devices.

Certain aspects of the described techniques include the process steps and instructions described herein in the form of algorithms. It should be noted that the process steps and instructions described can be embodied in software, firmware, or hardware, and when embodied in software can be downloaded to reside on a real-time network operating system and operated from different platforms used by the real-time network operating system.

The present disclosure also relates to an apparatus for performing the operations described herein. The apparatus may be specially constructed for the desired purpose, or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored on a computer-readable medium accessible by the computer. Such a computer program may be stored on a tangible computer-readable storage medium, such as, but not limited to, any type of disk, including a floppy disk, an optical disk, a CD-ROM, a magneto-optical disk, a read-only memory (ROM), a random access memory (RAM), an EPROM, an EEPROM, a magnetic or optical card, an application-specific integrated circuit (ASIC), or any other type of medium suitable for storing electronic instructions and each coupled to a computer system bus. In addition, the computers referred to in the specification may include a single processor or may be an architecture employing a multi-processor design for increased computing power.

FIG14 illustrates an embodiment of a diabetes management system. Server computer 18 may additionally or alternatively collect statistics indicating the number of user clicks (entries). The number of user clicks may be collected, for example, based on the number of user clicks on a website served by server computer 18 or the total number of user entries for synchronized diabetes management devices. By way of example only, server computer 18 may increment a fifth counter each time a user clicks a hyperlink on a website served by server computer 18. The value of the fifth counter may be displayed in response to a user request to view the number of user clicks on the website. In various implementations, server computer 18 may reset the fifth counter every predetermined period, such as once a day.

Server computer 18 may also or alternatively collect statistics indicating how many times various computing device operating systems have accessed the webpage served by server computer 18. Example operating systems include, for example, Microsoft Windows XP, Microsoft Windows Vista, Microsoft Windows 7, Microsoft Windows 8, other versions of Microsoft Windows, Apple Mountain Lion, Apple iOS, Google Chrome, Google Android, Linux, and other types of operating systems. Server computer 18 may count the number of times each different type of operating system has accessed the webpage. In various implementations, server computer 18 may collect the cumulative number of times the webpage has been accessed by two or more different operating systems. The collected counts for one or more operating systems may be displayed in response to a user request to view portal-type access counts. In various implementations, server computer 18 may reset the counts every predetermined period, such as once a day.

Example

The present technology is further illustrated by the following non-limiting examples.

Example 1

While reviewing the medical and usage data collected for a particular patient in a web portal, a healthcare provider may notice that statistics for one patient indicate that the patient has had five excessively high blood sugar readings since starting a new therapy regimen approximately a week ago. In some aspects, the diabetes management application will have already collected and analyzed this data, or statistics corresponding to this data, and may provide an alert to the healthcare provider that there have been multiple instances of excessively high or low blood sugar readings. Alternatively, the diabetes management application may detect that there are discrepancies in the usage data, such as that the user has not adhered to medication advisor settings or has not taken an appropriate number of blood sugar measurements within a given time period.

In light of the above, a healthcare provider can send an alert or message to the patient. In one aspect, the alert can include a reminder to take a blood glucose measurement. In another example, the alert can include instructions to perform a structured test. As an example, structured testing can involve a "Testing in Pairs" ("TIP") program, in which the patient is encouraged to focus on "before and after" testing, such as before and after a meal, before and after an exercise routine, before and after sleep, etc. This type of testing program can help in the sense of cause and effect and provide the ability to identify patterns in what might otherwise appear to be "random" testing throughout the day. Appropriate logic for determining such patterns, as well as the limits and boundaries for "normal" or "out-of-range" data, can be programmed into the recommended rule set 40, as shown in FIG5 and discussed above. Once the structured test is completed and the data is uploaded to a web portal and optionally analyzed and evaluated by the diabetes management system, the healthcare provider can be notified of the test completion.

In one example, a healthcare provider can review relevant medical and usage data and statistics and ultimately determine that the patient has excessive blood sugar after breakfast. During their last appointment with the patient, the healthcare provider adjusted the insulin: carbohydrate ratio for breakfast to be more aggressive due to the high blood sugar after breakfast. The healthcare provider can now see that the adjustment may be too aggressive and provides a less aggressive setting sent to a portable medical device such as a medication advisor, and sends an alert or message to the patient to perform another TIP for breakfast meals within a week. Once the TIP is completed and the data is uploaded to the web portal, a notification can be provided to the healthcare provider. The healthcare provider can then review the resulting data and any statistics accumulated and/or evaluated by the diabetes management application to determine whether the problem has been resolved.

Example 2

The healthcare provider filters all patient data associated with the healthcare provider's account on the web portal to identify all patients with any laboratory test data indicating an average blood sugar (glucose) level (HbA1c) greater than 7.5% over the past three months. For many patients, the goal may be to maintain this level at or below 6.5-7%. For patients with increased levels, the data in the web portal can be further filtered to determine which patients have not had an appointment with the healthcare provider in the past three months. This data can be manually obtained using the web portal, or the diabetes management system can be configured to provide the healthcare provider with a list of those patients, and the healthcare provider can send an alert or message to each patient to contact them to schedule an upcoming appointment. In some aspects, the diabetes management system can be configured to automatically run such queries at predetermined times and/or intervals.

Example 3

A healthcare provider recently changed a patient's therapy and added a GLP-1 (glucagon-like peptide 1 agonist) to help control post-meal glucose values. The patient may be provided instructions, via a web portal or diabetes management application, to perform pre- and post-meal testing for the most problematic meal of the day (breakfast). The healthcare provider may use the web portal to review the patient's medical and usage data over the following days. In one example, accumulated statistics indicate that the patient still has high post-breakfast glucose values. In certain aspects, this can be discovered by the diabetes management application comparing usage and medical data with values in a recommended rule set and noting any out-of-range data. The healthcare provider may be notified of this situation by receiving an alert via the web portal, or by reviewing data uploaded by a portable medical device. In response to the high glucose value, the healthcare provider may send an alert or message to the patient to increase their insulin dosage and continue to check pre- and post-breakfast glucose. The healthcare provider may continue to review the portal over the next few days and see that the patient's post-breakfast value is now within the normal range or target. The healthcare provider may send a follow-up alert, message, or note to the patient through the web portal to inform the patient that the revised dosage is correct and to follow up if the patient has any questions before the next office visit.

The foregoing description of the embodiments and examples has been provided for the purpose of illustration and description. It is not intended to be exhaustive or to limit the present disclosure. The individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable where applicable and can be used in selected embodiments, even if not specifically shown or described. This can also be varied in many ways. Such variations are not to be considered as departing from the present disclosure, and all such modifications are intended to be included within the scope of the present disclosure.

Claims (17)

1. A diabetes management system (10, 10', 30, 30') for monitoring multiple subcutaneous insulin injections, comprising: - Portable medical devices associated with patients (28); - A data repository accessible to both patients and healthcare providers (26); - A diabetes management application (33) configured to receive data from a portable medical device and store it in a data repository, the data including medical data associated with the patient and usage data associated with the patient's use of the portable medical device, wherein the usage data includes data indicative of the patient's adherence to medication recommendations, the data indicative of the patient's adherence including one or more of the following: ○ The number and timing of blood glucose measurements taken during the specified period; ○ The number, dosage, and timing of the prescribed medication treatments; ○ The number, amount, and duration of corrective treatments assigned; The diabetes management system is configured to collect statistics on the number of times medical data or usage data is synchronized with data stored in a data repository and to display the indicated number of times. The diabetes management application is configured to: accumulate and evaluate statistics related to the data used, including accumulating a certain number of hypoglycemic or hyperglycemic measurements of patients since the start of therapy-reduction and comparing the number of hypoglycemic or hyperglycemic measurements of patients since the start of therapy-reduction with the maximum acceptable value; and provide treatment recommendations to patients or healthcare providers when the statistics meet or exceed predetermined treatment guidelines, including providing treatment recommendations to patients or healthcare providers when the number of hypoglycemic or hyperglycemic measurements of patients since the start of therapy-reduction is greater than the maximum acceptable value. 2. The diabetes management system of claim 1 further includes: - Device transfer component (32), wherein the device transfer component is installed on a patient computing device (20) connected to one or more servers via a network (16), wherein the device transfer component enables the patient computing device to send data from a portable medical device to a diabetes management application (33) installed on one or more servers, thereby configuring the device transfer component to send the data to one or more servers via the network and to immediately erase any copies of the data from the device transfer component and/or from the patient computing device (20) after the data has been successfully sent. 3. The diabetes management system of claim 2, wherein the data transmitted via the device transfer component includes a unique identifier code for the portable medical device (28) from which the data is received; wherein one or more servers are configured to perform steps including: - Receive data with identifier codes from the device transfer component; - Assess whether the identifier code has been stored in association with the patient’s account in the diabetes management application (33), wherein the storage indicates successful registration of the portable medical device identified by the identifier code for the patient; - If the identifier code is already stored in association with the patient's account, the received data is automatically stored in the patient's account in the data store, thereby using the identifier code as the only necessary verification data for the patient and automatically verifying the patient at the diabetes management application via the identifier code; - If the identifier code is not already stored in association with the patient's account, prompt the patient to enter verification data via the user interface; evaluate the entered verification data; and only if the verification is successful, automatically store the received data in the patient's account in the data store, thereby storing the identifier code in association with the patient's account and automatically registering the portable medical device in the diabetes management application. 4. A diabetes management system according to any one of claims 1-3, wherein the diabetes management application is configured to remotely adjust at least one device setting on a portable medical device based on treatment recommendations. 5. The diabetes management system according to any one of claims 1-3 further includes one or more servers (18) configured to share information and manage the diagnosis and treatment of patients with medical conditions, the one or more servers being configured to perform the following steps: - Provides a web portal account accessible to both patients and healthcare providers, wherein the web portal account is associated with a portable medical device (28); - Receive (130) medical data and usage data from the portable medical device, the medical data being associated with the patient and the usage data indicating the patient’s use of the portable medical device; - Cumulative (140) refers to statistics on the use of data, where the statistics are accumulated over a period of time and are accessible in the web portal account; - Assess (150) statistics in relation to treatment guidelines; and - Send a (170) treatment recommendation to the patient or healthcare provider when at least one statistic meets or exceeds the treatment criteria. 6. The diabetes management system of claim 5, wherein the statistics indicate at least one of blood glucose measurement, carbohydrate consumption, medication treatment, basal rate, and adherence to treatment recommendations. 7. The diabetes management system of claim 5, wherein one or more servers are further configured to accumulate statistics from multiple portable medical devices associated with the patient. 8. The diabetes management system of claim 5, wherein one or more servers are further configured to provide one or more proposed treatment recommendations to a healthcare provider, thereby enabling the healthcare provider to select at least one proposed treatment recommendation and send the selected treatment recommendation to a patient computing device (20). 9. The diabetes management system of claim 5, wherein treatment recommendations include at least one of reminders regarding dietary habits, reminders for transferring data from a portable medical device to a web portal account, reminders for testing blood glucose levels, recommendations for correcting basal rate changes, and recommendations for correcting medication dosage. 10. The diabetes management system of claim 5, wherein the data associated with the web portal account is accessible via a portable medical device. 11. The diabetes management system according to any one of claims 1-3 further includes one or more servers (18) configured to manage multiple subcutaneous insulin injection courses for a patient, the one or more servers being configured to perform the following steps: - Provides a web portal account accessible to both patients and healthcare providers, wherein the web portal account is associated with a portable medical device (28); - Receive (130) medical data and usage data from the portable medical device, the medical data being associated with the patient and the usage data indicating the patient’s use of the portable medical device; - Cumulative (140) refers to statistics on the use of data, where the statistics are accumulated over a period of time and are accessible in the web portal account; - Assessment of (150) statistics in relation to treatment guidelines; - Associate statistics with a web portal account (160) for access by one or both of the patient and the healthcare provider; and - Provide treatment recommendations to patients or healthcare providers when at least one statistic meets or exceeds predetermined treatment criteria. 12. A diabetes management system according to any one of claims 1-3, wherein treatment recommendations include adjustment of the patient's insulin:carbohydrate ratio. 13. The diabetes management system of claim 5, wherein one or more servers are further configured to send treatment recommendations as electronic messages to portable medical devices. 14. The diabetes management system of claim 13, wherein one or more servers are further configured to solicit input from a healthcare provider before sending treatment recommendations to the patient's computing device (20). 15. The diabetes management system of claim 5, wherein one or more servers are further configured to remotely adjust at least one device setting on a portable medical device (28) based on treatment recommendations. 16. The diabetes management system of claim 15, wherein the device settings include at least one of insulin: carbohydrate ratio, basal rate, maximum dosage, calibration settings, utility settings, and alarm settings. 17. The diabetes management system of claim 5, wherein one or more servers are configured to enable healthcare providers to select the type of statistics used for assessment.